HOJA DE HALLAZGOS

143. In one of Wakefield’s prior lawsuits against me in the UK (Wakefield v Channel 4 & Ors.), his lawyers in 2006 disclosed to me a series of Royal Free pro forma reports, aggregating histories and other data from the children. These were documents from his research, supplied by him. Indeed, he relied on pro formas from this series in his book, perversely titled Callous Disregard, the relevant chapter from which I have attached as Exhibit 42.

144. Wakefield abandoned his lawsuit before trial so, in accordance with UK civil procedure rules, I did not report the contents of these documents in my articles. They were, however, in my mind at the time I wrote the “Secrets” series, and they informed my evaluation of his research and integrity. The forms were powerful confirmation that there was something seriously wrong with the Lancet paper and with his conduct in writing it.

145. I attach as Exhibits 43-47 copies of five of these forms: specifically those for Child 1, Child 6, Child 12, Child 11 and Child 5, respectively. These are half (four) of the eight children whose parents were reported in the paper to have blamed MMR, plus one of three further children whose parents’ made the same critical disclosure when they came to the hospital, but which was withheld from the journal so as to generate the published eight of 12 figure. The reports are headed:

Report on the investigation into the possible link between viral exposures and developmental disorders in children

146. When passed from Wakefield’s London lawyers to my London lawyers in 2006, these reports (and others from the Lancet series) were redacted on their first pages for the children’s names and other identifying information. The reports came to me bundled together with some three dozen further such reports on children who were not included in the Lancet series. Thus, effective redaction of the identifying information would render the documents useless to me for any substantial evidential purpose. I would be in a similar position to Wakefield’s co-authors when they reviewed the paper before publication. I would not know which child was which and, therefore, would be unable to cross-check data.

147. However, perhaps following oversight by Wakefield’s lawyers, I found that each child’s name and hospital patient number had survived, unredacted, in a histology section inside each report. Thus, vital information about what he knew of these patients was revealed to me.10

Child 1 – Exhibit 43

148. According to Table 2 of the paper, in the case of Child 1, the “interval from exposure to first behavioural symptom” of what was tabulated as a subsequent “behavioural

10 _{Some of the reports were missing from the disclosure, including those for Child 2 and Child 7. In Exhibits}

43-47, I have redacted the information identifying the children. Also, some years ago, for my own reference, I made a few handwritten notes on the documents, and on the first page I pasted a portion of text taken from a table contained in a bespoke document served on me by Wakefield during the previous lawsuit. These should generally be disregarded.

diagnosis” of autism was given as “1 week”. As I have previously shown, this brief interval – even for just this first of the eight children – was critical to generate the paper’s 14-day maximum/6.3 day average temporal link. This link was the paper’s only evidence incriminating MMR as a possible cause of autism. Moreover, it was not left as a mere parental allegation, but was adopted as fact and tabulated as fact – purportedly supported by a review of children’s records.

149. However, the Royal Free report at Exhibit 43 disposes of any such claim, and confirms hospital records presented at the GMC hearing. At page 3, a box asks whether the child’s initial development was normal, and, if answered “Yes”, asks “If Yes, until when?” It then gives “Age”, and provides a box to be completed. The box was completed:

18 months

150. At page 5 of the report, the age of the child at the date of MMR vaccination is given as: “12 months” (with the date). Thus, according to confidential records from the project, disclosed in litigation, the child is reported to have experienced normal behavioural development (which obviously must preclude symptoms of autism) for six months after MMR, and not one week as claimed in the paper.

151. But exactly what was the first “behavioral symptom” (precursor to a purported “behavioural diagnosis” of autism), according to his own project’s pro forma record- keeping? Returning to page 3, the report contains a box headed: “Initial behavioural abnormality (specify):”

152. The box is completed in terms entirely incompatible with the Lancet paper, and entirely compatible with the case presented at the GMC and in the BMJ:

At 18 months noted to have lost words and no longer progressing in speech, comprehension and social interaction.

153. Moreover, despite Wakefield’s claims in the Lancet and throughout his campaign against MMR (including a core distinction he made between “regressive” and

“classical” autism) that this child had regressive autism, a box on page 3 is headed “Initial diagnosis:”. There are no other diagnosis boxes completed on the form. This box is completed:

Classical Autism

154. Finally with regard to Child 1, page 5 contains a box with the heading: “Adverse reactions, related vaccine and interval from first symptom:” This is answered (my emphasis): 7-10 days after MMR vaccination [Child 1] had a brief illness – pale, possibly pyrexial and delirious.

155. Thus – as evidenced at the GMC hearing and accurately explained in the first “Secrets” article – the only symptom reported to have been positively asserted by the mother as associated in time with MMR was that, 7-10 days later, her son was pale. And yet, deleting question-marks, Wakefield adopted as fact that this (possibly feverish) episode was the first “behavioural symptom” of regressive autism“1 week” after MMR, and used it to generate the bogus 14-day maximum/6.3 day average temporal link.

Child 6 – Exhibit 44

156. On page 1 of Child 6’s Royal Free report is a summary box headed “Clinical diagnosis”. It is completed:

Lymphonodular hyperplasia, non specific colitis and Aspergers

157. On page 3, the report asks with regard to the patient “Initial development – normal:” so as to ask a question to be answered. It may be recalled from the Lancet “abstract” that the paper’s Interpretation section described the patients reported within it as “a group of previously normal children” (my emphasis).

158. Nevertheless, in response to the pro forma question as to whether Child 6’s initial development was normal, the report answers squarely:

159. Also on page 3 is a box headed “Initial diagnosis:” The box is completed: “Aspergers Syndrome”. Wakefield, however, did not enter this information in the Lancet. According to the paper, this child had a “regressive developmental disorder” with Table 2 falsely completed “Autism”.

160. Asperger’s syndrome is neither a regressive developmental disorder, nor is it, by definition under the nosology claimed in the paper to be relied upon by Wakefield, a “behavioural” or “developmental” diagnosis of autism. Subsequent boxes on page 3 of the report show that Child 6 was diagnosed at a specialist child development centre in Brighton (60 miles south of London) by a specialist paediatrician, and confirmed at Guy’s hospital, London (a flagship UK medical centre), by a Dr Gillian Baird, who I established (and made a note of on the form) to be a “consultant developmental pediatrician” at a specialist assessment unit.

161. No developmental paediatrician saw this boy at the Royal Free, which had no centre for developmental issues and (probably unknown to the parents) almost no expertise in evaluating them. Nevertheless, a final box on page 3 is headed: “Current diagnosis (RFH):” (meaning Royal Free Hospital). The box is completed:

Aspergers Syndrome (most likely).

162. In 2007, or thereabouts, I appended a handwritten note stating (from the GMC proceedings) that this tentative diagnosis was confirmed in a “Berelowitz letter to W”, meaning a letter from the Royal Free child psychiatrist, Dr Mark Berelowitz, to Wakefield. Indeed, the information contained here (and elsewhere in the pro forma reports) is wholly consistent with material presented at the GMC and accurately reported in the BMJ.

163. Among other things, on page 4 of the report for Child 6 is a tabulation of vaccinations received by this little boy, with the dates of administration. The tabulation notes a third DTP vaccination on 1 January 1992 and an MMR vaccination, 18 months later, on 15

June 1993. Turning to page 5, we come to a box headed “Adverse reactions, related vaccine and interval from first symptom:” This is followed by two paragraphs, one relating to DTP and the other to MMR (My emphasis):

After 3rd DPT vaccination [Child 6] was described by [his mother] as crying too much and having a high pitched scream 5 minutes post vaccination. This persisted for 12 hours. [Child 6] then described as having an episode of ‘two tone colour’ – near cot death – admitted to the Ipswich Hospital for 2 days for observation.

Fever, constant cold and blotchy rash one week after receiving MMR vaccination. This lasted for 2 weeks. Behaviour became aggressive. 2 months later [Child 6] developed abdominal pain prior to defaecation, sometimes passing blood and mucous in stool.

164. We then learn from the report the surprising information that the mother did not even initially blame MMR at all. Returning to page 4, we find a box headed “Outcome/complications (specify infection and complications):” which is completed only with regard to MMR It says (my emphasis):

Measles rash noted by [Mrs 6] 1 week prior to MMR vaccination. Dr advised that MMR be administered regardless. (history taken by Professor Walker-Smith at OPA on 02.10.96. Reported by GP Dr Ball in a letter dated 03.04.93 that [Mrs 6] concerned that since measles infection [Child 6] had been generally unwell. Reported as developing sudden pyrexia’s and listlessness.

165. In fact, other medical records presented at the GMC hearing showed that the measles infection was some three months before MMR and not one week as evidently misreported to Walker-Smith by the mother when she came to what is reported above as the “OPA” (outpatient appointment – before admission). It should be noted that GP Dr Ball’s letter of 1993, referring to measles, was written before the mother had heard of Wakefield.

166. In summary: Wakefield claimed in the Lancet that Child 6 was “previously normal” and showed the “first behavioural symptom” of regressive autism “1 week” following MMR. But there is nothing in this Royal Free report, or in the contemporaneous documentation reviewed by the GMC panel, to substantiate any of these claims.

Child 12 – Exhibit 45

167. As with Child 6, Wakefield asserts in Table 2 of his paper that Child 12 had a “behavioural diagnosis” of “Autism”. However, the Royal Free report on this child, again, tells a different story. On page 1 is a box headed “Clinical diagnosis:” This box is completed:

Aspergers Syndrome

Ileal lymphonodular hyperplasia and mild colitis

168. As I will explain below, under the nosology explicitly stated by Wakefield to have been employed, Asperger’s syndrome is a different diagnosis to autism, and is not regressive.

169. I believed, in 2006 and at all times since, that the reason Wakefield did not tabulate the true diagnosis was because, prior to the UK MMR litigation being filed (in October 1998), he was attempting to convince the Lancet’s editors, peer reviewers and readers – and also most vitally his funders at the Legal Aid Board – that he had discovered a coherent “new syndrome” of regressive autism and inflammatory bowel disease, putatively caused by MMR.

170. At page 3 of Child 12’s report, the diagnosis is restated in terms wholly concordant with records presented at the GMC hearing. A box headed “Initial diagnosis:” is completed “Aspergers 11 September 1996” This date is one month after the boy first attended an outpatient clinic at the Royal Free. Another box, at the foot of page 3, is headed: “Current diagnosis (RFH):” It is completed:

Language Delay

Possible Attention Deficit Disorder Possible Features of Asperger’s

171. Language delay is not an autistic spectrum disorder, and there is no reference in the report to any diagnosis of autism.

Child 11 – Exhibit 46

172. The report for Child 11 contains information suggesting that it is based at least in part on a medical report which the parents (who travelled with their son from California) had sent to Wakefield in January 1997 (Ex. 48). At page 5 of the pro forma, a “vaccination history” box contains information for “MMR”. It gives the date he received the vaccine as:

7.5.92 (15 months)

173. Returning to page 3 of the report, at the top of the page is a summary section. This asks the question: “Initial development – normal:” which is answered: “Yes”. In the following line, the question is asked “If Yes, until when?” The question is answered with “Age” and then a box for the age to be given. The box has been completed:

13 months

174. This date would be before Child 11 received MMR.

175. Also at page 3 is a box headed: “Initial behavioural abnormality (specify):” The first line of the response is completed thus:

18 months: Slowed speech patterns ?one history says symptoms from 13 months 176. At page 5 of the report, following a “vaccination history” table, is a box with several headings, the first of which is “Adverse reactions, related vaccine and interval from first symptom:” This box is completed:

MMR: Viral infection, with cough & intermittent fever. Followed by viral pneumonia. Suggested Mycoplasmium pneumonia

177. A second heading asks: “By whom was the reaction noted?” The answer is given:

Doctor visited (9.6.92 & 23.6.92)

178. On this detailed and specific information, plainly drawn from records, the doctor first visited 32 days after Child 11 (whose parents are wealthy and highly educated) received MMR. This visit was in response to an apparent viral chest infection. This is clearly not a

credible example of what the pro formas call an “initial behavioural abnormality” and the Lancet paper – meaning the same thing – calls a “first behavioural symptom”.

179. And yet, notwithstanding 32 days elapsing before the doctor arrived, and notwithstanding the diagnosis of a viral infection, Wakefield’s paper tabulates the “interval from exposure to first behavioural symptom” for this boy as “1 week” – a claim unsupported in any aspect anywhere in the pro forma report, or even later in Wakefield’s book. This claim was further denied by the father, in 2011 correspondence to me and Daniel Olmstead (a Wakefield cohort), as an “outright fabrication” (Ex. 49).

180. And, yet again, this bogus “1 week” interval – exactly the same time period as falsely reported for Child 1 – was critical to Wakefield’s mission.

Child 5 – Exhibit 47

181. I have previously explained that Wakefield omitted three parental disclosures of an alleged MMR-autism association, so as to reduce the 11 of 12 figure logged at the hospital to 8 of 12 and thereby obtain the 14-day maximum/6.3 day average temporal link. As I state in the first “Secrets” report (with its footnote 92), Royal Free records show that the parents of Child 5 were among those who blamed MMR for the onset of their child’s autism, but whose critical disclosure at the hospital was withheld from the paper. The pro forma report confirms this. A box at page 3 is headed “Initial behavioural abnormality (specify):” This is completed:

Loss of language – less sociable – began making strange noises. Lost interest in his surroundings.

Diagnosed as deaf at 2 years of age.

182. Under a “Vaccination history” table on page 5 is a box with three headings, the first of which is “Adverse reactions, related vaccine and interval from first symptom:”. The response is completed:

MMR – 2 months later ‘growling voice’ and loss of speech.

Parents

184. Nevertheless, Table 2 of the paper records the “Exposure identified by parents or doctor” as “None – MMR at 16 months”. The child’s case, with its inconvenient two- month time-frame, is also omitted from the calculation performed by Wakefield to generate the 14-day maximum/6.3 day average temporal link.

185. This child’s gastroenterology status was also altered. On page 6 is a box with details of colonoscopy findings, giving the endoscopist’s name (Dr Simon Murch) and the procedure date. Under “Findings” is a paragraph which concludes with the sentence (my emphasis):

There were prominent follicles in the ileum, but not sufficient to call lymphoid hyperplasia. The ileal mucosa appeared fully normal.

186. The title of Wakefield’s paper, and his claim of a new bowel disease, included the expression “ileal lymphoid nodular hyperplasia” (LNH) – meaning swollen lymph glands in the distal small bowel. However, as can be seen here, the endoscopist explicitly ruled out this finding for Child 5. I attach a corresponding extract from the GMC transcript as Exhibit 50, where an identical text of the endoscopy report was evidenced.

187. Nevertheless, for the paper’s Table 1, the finding was altered – from an entirely normal observation in the small bowel to one of purported disease. Under “Endoscopic findings” the paper records:

LNH of T ileum

Once again, the data was changed and misreported.